Myriad Genetics: In the Eye of the Policy Storm

Overview

Journal Genet Med

Publisher Elsevier

Specialty Genetics

Date 2010 Apr 16

PMID 20393310

Citations 28

Authors

E Richard Gold

Julia Carbone

Affiliations

Soon will be listed here.

Abstract

From the late 1980s, a storm surrounding the wisdom, ethics, and economics of human gene patents has been brewing. The various winds of concern in this storm touched on the impact of gene patents on basic and clinical research, on health care delivery, and on the ability of public health care systems to provide equal access when faced with costly patented genetic diagnostic tests. Myriad Genetics, Inc., along with its subsidiary, Myriad Genetic Laboratories, Inc., a small Utah-based biotechnology company, found itself unwittingly in the eye of this storm after a series of decisions it made regarding the commercialization of a hereditary breast cancer diagnostic test. This case study examine the background to Myriad's decisions, the context in which these decisions were made and the policy, research and business response to them.

Citing Articles

GeneHome - a Novel Model to Deliver Care to Individuals with Genetic Predisposition to Cancer.

Nocera Zachariah N, Lee M, Chang M, Moore C, Wang X Cancer Control. 2022; 29:10732748221109951.

PMID: 35976772 PMC: 9393671. DOI: 10.1177/10732748221109951.

Inverting the model of genomics data sharing with the NHGRI Genomic Data Science Analysis, Visualization, and Informatics Lab-space.

Schatz M, Philippakis A, Afgan E, Banks E, Carey V, Carroll R Cell Genom. 2022; 2(1).

PMID: 35199087 PMC: 8863334. DOI: 10.1016/j.xgen.2021.100085.

The fall of the innovation empire and its possible rise through open science.

Gold E Res Policy. 2021; 50(5):104226.

PMID: 34083844 PMC: 8024784. DOI: 10.1016/j.respol.2021.104226.

Framing Ethical Concerns and Attitudes towards Human Gene Patents in the Chinese Press.

Du L, Lin S, Kamenova K Asian Bioeth Rev. 2021; 12(3):307-323.

PMID: 33717340 PMC: 7747419. DOI: 10.1007/s41649-020-00136-0.

The Bermuda Triangle: The Pragmatics, Policies, and Principles for Data Sharing in the History of the Human Genome Project.

Maxson Jones K, Ankeny R, Cook-Deegan R J Hist Biol. 2018; 51(4):693-805.

PMID: 30390178 PMC: 7307446. DOI: 10.1007/s10739-018-9538-7.

References

Lynch H, Snyder C, Lynch J, Karatoprakli P, Trowonou A, Metcalfe K . Patient responses to the disclosure of BRCA mutation tests in hereditary breast-ovarian cancer families. Cancer Genet Cytogenet. 2006; 165(2):91-7. DOI: 10.1016/j.cancergencyto.2005.07.011. View

Walsh T, Casadei S, Coats K, Swisher E, Stray S, Higgins J . Spectrum of mutations in BRCA1, BRCA2, CHEK2, and TP53 in families at high risk of breast cancer. JAMA. 2006; 295(12):1379-88. DOI: 10.1001/jama.295.12.1379. View

Miller F, Giacomini M, Ahern C . Contending visions in the evolution of genetic medicine: the case of cancer genetic services in Ontario, Canada. Soc Sci Med. 2008; 67(1):152-60. DOI: 10.1016/j.socscimed.2008.03.035. View

Rabino I . How human geneticists in US view commercialization of the Human Genome Project. Nat Genet. 2001; 29(1):15-6. DOI: 10.1038/ng0901-15. View

Caulfield T . Underwhelmed: hyperbole, regulatory policy, and the genetic revolution. McGill Law J. 2003; 45(2):437-60. View

Cho M, Illangasekare S, Weaver M, Leonard D, Merz J . Effects of patents and licenses on the provision of clinical genetic testing services. J Mol Diagn. 2003; 5(1):3-8. PMC: 1907368. DOI: 10.1016/S1525-1578(10)60444-8. View

Matthijs G, Halley D . European-wide opposition against the breast cancer gene patents. Eur J Hum Genet. 2002; 10(12):783-5. DOI: 10.1038/sj.ejhg.5200924. View

Caulfield T, Cook-Deegan R, Kieff F, Walsh J . Evidence and anecdotes: an analysis of human gene patenting controversies. Nat Biotechnol. 2006; 24(9):1091-4. PMC: 2701726. DOI: 10.1038/nbt0906-1091. View

. Statement of the American Society of Clinical Oncology: genetic testing for cancer susceptibility, Adopted on February 20, 1996. J Clin Oncol. 1996; 14(5):1730-6; discussion 1737-40. DOI: 10.1200/JCO.1996.14.5.1730. View

10.

Miller F, Giacomini M, Ahern C, Robert J, de Laat S . When research seems like clinical care: a qualitative study of the communication of individual cancer genetic research results. BMC Med Ethics. 2008; 9:4. PMC: 2267198. DOI: 10.1186/1472-6939-9-4. View

11.

Williams-Jones B, Graham J . Actor-network theory: a tool to support ethical analysis of commercial genetic testing. New Genet Soc. 2004; 22(3):271-96. DOI: 10.1080/1463677032000147225. View

12.

Nicol D . Balancing innovation and access to healthcare through the patent system--an Australian perspective. Community Genet. 2005; 8(4):228-34. DOI: 10.1159/000087960. View

13.

Hall M, McEwen J, Barton J, Walker A, Howe E, Reiss J . Concerns in a primary care population about genetic discrimination by insurers. Genet Med. 2005; 7(5):311-6. DOI: 10.1097/01.gim.0000162874.58370.c0. View

14.

Gollust S, Hull S, Wilfond B . Limitations of direct-to-consumer advertising for clinical genetic testing. JAMA. 2002; 288(14):1762-7. DOI: 10.1001/jama.288.14.1762. View

15.

Williams-Jones B . History of a gene patent: tracing the development and application of commercial BRCA testing. Health Law J. 2004; 10:123-46. View

16.

Benowitz S . European groups oppose Myriad's latest patent on BRCA1. J Natl Cancer Inst. 2003; 95(1):8-9. DOI: 10.1093/jnci/95.1.8. View

17.

Malakoff D . Intellectual property. NIH roils academe with advice on licensing DNA patents. Science. 2004; 303(5665):1757-8. DOI: 10.1126/science.303.5665.1757a. View

18.

Marshall E . The battle over BRCA1 goes to court; BRCA2 may be next. Science. 1998; 278(5345):1874. DOI: 10.1126/science.278.5345.1874. View

19.

Puget N, Stoppa-Lyonnet D, Sinilnikova O, Pages S, Lynch H, Lenoir G . Screening for germ-line rearrangements and regulatory mutations in BRCA1 led to the identification of four new deletions. Cancer Res. 1999; 59(2):455-61. View

20.

Mouchawar J, Laurion S, Ritzwoller D, Ellis J, Kulchak-Rahm A, Hensley-Alford S . Assessing controversial direct-to-consumer advertising for hereditary breast cancer testing: reactions from women and their physicians in a managed care organization. Am J Manag Care. 2005; 11(10):601-8. View